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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K253033

510(k) cleared

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

Simplivia Healthcare , Ltd. · Oct 21, 2025 · K253033

FDA cleared the Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor from Simplivia Healthcare , Ltd. on Oct 21, 2025 under K253033, a special 510(k). The device falls under product code ONB, Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 22, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Simplivia Healthcare , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253033?

K253033 is the FDA 510(k) for Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor, submitted by Simplivia Healthcare , Ltd.. FDA's decision date was Oct 21, 2025, under product code ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System).

Who makes the Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor?

Simplivia Healthcare , Ltd., based in Kiryat Shmona, is the applicant of record for K253033.

How long did the K253033 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Oct 21, 2025, 29 days later.

← All decisions in October 2025